BioPro K-Wire Sterile Single Trochar Recalled for Sterile Barrier Flaw
BioPro, Inc. is recalling K-Wire Sterile Single Trochar units due to a manufacturing flaw in the sterile barrier system that may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile barrier flaw in a medical device, which poses a risk of infection (risk-of-harm product) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BioPro, Inc. is recalling 6 units of the K-Wire Sterile Single Trochar, Item Number 19106. The product is an accessory to the BioPro Go-Ez screw system and the BioPro HBS System, intended for various orthopedic surgical procedures but not for use in the spine.
The recall is due to a manufacturing flaw in the sterile barrier system. This defect may compromise the sterility of the device. The affected units have UDI M209191060, Lot Number 123130, and a manufacturing date of 4/29/2019.
The products were distributed worldwide, including in the US states of Florida, Louisiana, Maryland, North Carolina, New York, Oregon, and Texas, as well as in Ecuador and Scotland. Users should stop using the affected devices and contact BioPro, Inc. for instructions on return or replacement.
The recalled product
- Product
- K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
- Manufacturer
- BioPro, Inc.
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI - M209191060 Lot Number - 123130 MFG Date - 4/29/2019
Distribution
Part of a larger recall action
This product is one of 21 recalled by BioPro, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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